WARNINGS

There have been isolated reports of hypopigmentation after use of azelaic acid. Since azelaic acid has not been well studied in patients with dark complexions, these patients should be monitored for early signs of hypopigmentation.

PRECAUTIONS

General

If sensitivity or severe irritation develop with the use of AZELEX (azelaic acid cream) Cream, treatment should be discontinued and appropriate therapy instituted.

Carcinogenesis, mutagenesis, impairment of fertility:

Azelaic acid is a human dietary component of a simple molecular structure that does not suggest carcinogenic potential, and it does not belong to a class of drugs for which there is a concern about carcinogenicity. Therefore, animal studies to evaluate carcinogenic potential with AZELEX (azelaic acid cream) Cream were not deemed necessary. In a battery of tests (Ames assay, HGPRT test in Chinese hamster ovary cells, human lymphocyte test, dominant lethal assay in mice), azelaic acid was found to be nonmutagenic. Animal studies have shown no adverse effects on fertility.

Pregnancy

Teratogenic Effects: Pregnancy Category B.

Embryotoxic effects were observed in Segment I and Segment II oral studies with rats receiving 2500 mg/kg/day of azelaic acid. Similar effects were observed in Segment II studies in rabbits given 150 to 500 mg/kg/day and in monkeys given 500 mg/kg/day. The doses at which these effects were noted were all within toxic dose ranges for the dams. No teratogenic effects were observed. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

Equilibrium dialysis was used to assess human milk partitioning in vitro.
At an azelaic acid concentration of 25 µg/mL, the milk/plasma distribution coefficient
was 0.7 and the milk/buffer distribution was 1.0, indicating that passage of
drug into maternal milk may occur. Since less than 4% of a topically applied
dose is systemically absorbed, the uptake of azelaic acid into maternal milk
is not expected to cause a significant change from baseline azelaic acid levels
in the milk. However, caution should be exercised when AZELEX (azelaic acid cream) Cream is administered
to a nursing mother.

Pediatric Use

Safety and effectiveness in pediatric patients under 12 years of age have not been established.

Geriatric Use

Clinical studies of AZELEX (azelaic acid cream) Cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Last reviewed on RxList: 11/11/2008
This monograph has been modified to include the generic and brand name in many instances.